1. Field of Invention
This invention relates generally to systems, devices and methods for containing instruments and other similar devices during low temperature sterilization processes employing an electric field and, following sterilization, sealing the sterilized instruments and devices in said container.
2. Description of Prior Art
This invention relates generally to systems, devices and methods for containing instruments and other similar medical devices during low temperature sterilization processes utilizing an electric field such as those described in U.S. Pat. No. 4,643,876, U.S. Pat. No. 4,756,882 and U.S. Pat. No. 5,750,072.
Recent practices and regulations define the requirement for packaging methods and means to assure the preservation of the sterilized condition of medical devices and objects which have been sterilized by low temperature non radiation means. These requirements are presently accomplished by several steps or procedures;
First, the medical device(s) or object(s) to be sterilized are inserted in a package or enclosure fabricated of a material or means which will permit transfer of sterilant. The package completely surrounds the device(s) PA1 Next, the opening of the package or enclosure is completely sealed, PA1 Then, the device(s) or object(s) in their sealed package are placed in a sealed sterilizer compartment, PA1 Where, a vacuum is created, PA1 While a sterilant in plasma or vapor form is introduced into the chamber, PA1 With the sterilant penetrating the package due to the pressure differential between the chamber and the package, PA1 Following which the vacuum is released, PA1 Which is followed by the creation of a new vacuum PA1 And sterilant plasma or vapor is again introduced into the chamber. To assure effective exposure of the sterilant to all surfaces of the packaged medical devices and objects these processes normally require a sequence of infusions and subsequent evacuations of the sterilant to and from the permeable package. PA1 Use of an open container to hold medical devices and objects during a low temperature sterilization process. The open container assures direct and maximum exposure of the contained devices and objects to the sterilant. This direct method eliminates the extended cycles and time required by other systems to assure sterilant penetration of a sealed closed packaging barrier. PA1 Following completion of the sterilization cycle, evacuation of moisture from the open containers is accomplished by a blower system followed by closure of the container. Thereby assuring complete desiccation of the devices and objects. This method reduces the extended time required by other systems which evacuate sterilant residuals and by-products through sealed, closed instrument packaging PA1 A method and means to assure an integral bond and complete seal between the container and its closures. Thereby assuring complete and impervious containment of the sterilized medical instruments and devices. Other processes utilize sealed closed instrument and device packaging through which sterilant and its by products are inserted and removed. The processed instruments in the same sealed packaging are inventoried prior to use. The potential for penetration of contaminants is apparent. PA1 A means and method for sealing the container immediately following completion of sterilization while it remains in the sterilized field. PA1 Still further objects and advantages will become apparent from a consideration of the ensuing description and accompanying drawings.
These processes and sequences require significant time to complete sterilization. In part due to the restrictions on exposure of the sterilant to the devices and objects imposed by the packaging barrier. Certain of these systems produce potentially harmful vapors or chemical residuals which require evacuation procedures and substantial additional time to dissipate.
Our invention positions a specially designed open container holding the medical devices and objects to be sterilized within the cabinet of a low temperature electric field sterilizing system as taught by U.S. Pat. No. 4,643,876, U.S. Pat. No. 4,756,882 and U.S. Pat. No. 5,750,072. The container is open at the top with an open grid bottom to assure complete exposure of the medical devices and objects to the sterilant introduced into the sterilizing cabinet or processing section of a continuous process system.
This method allows shortening the exposure time required to provide sterilization as the medical devices and objects are directly exposed to the sterilant.
Following completion of the sterilization cycle, sterile desiccated air is introduced into the sterilizer cabinet or processing section to remove any residual moisture from the medical devices and objects .
Following moisture purging, the containers are moved through a series of rollers, which slowly closes the top and bottom lids of the container. The pressure from these rollers ensures that the plastic male ridge in each lid engages the female ridged groove in the body of the container, thereby sealing the top and bottom lids. The type of plastic from which the containers are formed permit momentary transitional distortion without any residual memory or effect of the distortion being retained. Clearances designed into the retainer groove and ridged rims on the lids anticipate momentary distension of the plastic to create a pressure fit.
To further assure a complete seal between the rim appendage and the retainer groove of the closure, a sealant containment strip may be inserted in the groove of the top and bottom closures. Mechanical pressure asserted on the top and bottom closures fractures capsules of the sealant containment strip releasing the sealant.
Dependent on the type of plastic and construction of the container these capsules may contain chemicals which polymerize the plastic of the retainer groove to effect an integral bond between the closure and body of the container. Alternatively, the sealant capsules may contain a pliant material which, when released by pressure fracture, surrounds the ridge of the container side sealing the closure to the body of the container.
In the batch processing configuration of our system when all of the containers have been sealed, the sterilization chamber is opened and the carriers holding the containers are moved to a location where the sterilized containers are removed from the carrier, labeled and placed in inventory. Alternatively, in the continuous production line processing configuration of our system the containers are moved along a conveyor system through the sterilizing field, drying section, the closure system and finally, to an inventory holding area.
Due to the normal temperature differential found in most environments using medical instruments and devices relative to that of the sterilization system enclosure, the now sealed containers will develop a nominal vacuum.
The containers are designed to be injection molded from a clear plastic material to assure direct visual confirmation of the contents of each container.
In sterile environments as in an operating room, containers without top or bottom lids may be utilized eliminating the requirement for sealing the container lids.
In certain sterilization systems as in U.S. Pat No. 5,750,072, sterilization may be effected in less than a minute. Such a system utilizing the container and methods described herein permit a significant reduction in the time required to sterilize instruments and devices thereby reducing sterilization costs while improving instrument and device utilization.